New Annex of Part C Published: A Step Forward in Handling Confidential Co-Formulant Information
New Annex of Part C Published: A Step Forward in Handling Confidential Co-Formulant Information
On May 25th, 2025, the European Commission published a new Annex of Part C of the dRR dossier aimed at streamlining how confidential co-formulant information is shared in the context of PPP (Plant Protection Product) authorisation under Regulation (EU) No 1107/2009. This long-awaited update introduces a standardised format that Member States (MS) must now use whenever confidential information, specifically related to co-formulants, is submitted directly to the zonal Rapporteur Member State (zRMS) by suppliers and is not known to the applicant.
Until now, the process for managing such confidential data has been fragmented and inefficient, with suppliers often needing to submit the same sensitive information multiple times to different MS. This has been a persistent source of delays and inconsistency across dossiers.
With this new annex:
- The zRMS will centralise and upload the co-formulant information onto CIRCABC.
- The annex will include full compositions of co-formulants (submitted directly by suppliers if confidential) and assessments of equivalence for proposed alternatives.
- The format provides space for detailed toxicological, ecotoxicological, and physico-chemical assessments of equivalency between registered and alternative co-formulants.
- It must also be completed when a co-formulant is listed in Annex III of Regulation (EU) 1107/2009.
- If a co-formulant is found unacceptable (e.g. based on REACH, CLH, RAC), the MS must notify the Commission to propose its inclusion in Annex III of Regulation (EC) No 1107/2009, as per Regulation (EU) 2023/574.
This annex improves efficiency by securely standardising how confidential co-formulant data is shared across cMS, reducing admin burden and supporting faster, more consistent evaluations.
If you need advice or assistance with the regulation of plant protection products, fertilising products, biocides or chemicals in the EU and UK, please do not hesitate to contact the experts at Kerona info@kerona.ie